Trial of Efficacy and Safety of NS-229 Versus Placebo in Patients With Eosinophilic Granulomatosis With Polyangiitis

Churg-Strauss Syndrome Clinical Trial

Official title:

A Phase 2, Double-blind, Randomized, Placebo-controlled Study to Investigate the Efficacy and Safety of NS-229 in the Treatment of Eosinophilic Granulomatosis With Polyangiitis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06046222
• Other study ID #: NS229-P2-01
• Status: Recruiting
• Phase: Phase 2
• Start date: December 20, 2023
• Est. completion date: May 2025

Study information

• Verified date: April 2024
• Source: NS Pharma, Inc.
• Contact: NS Pharma, Inc.
• Phone: 1-866-677-4276
• Email: trialinfo[@]nspharma.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will enroll male and female subjects who are 18 years of age or older with Eosinophilic Granulomatosis With Polyangiitis.

Description:

The purpose of this randomized, double-blind study is to investigate the efficacy and safety of NS229 compared with placebo over a 28-week study treatment period in subjects with Eosinophilic Granulomatosis with Polyangiitis (EGPA) receiving background corticosteroid therapy with or without mepolizumab therapy. During the treatment period corticosteroid dose will be tapered. The key outcomes in the study focus on evaluation of clinical remission, defined as Birmingham Vasculitis Activity Score (BVAS)=0 with a corticosteroid dose of <=4 mg/day prednisolone/prednisone.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: May 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Ability to provide written informed consent prior to participation in the study.
• Male or female subjects aged =18 years at the time the informed consent form is signed.
• Diagnosis of EGPA: Subjects who have been diagnosed with EGPA based on the history or presence of eosinophilia plus at least a history or presence of 2 of additional features of EGPA.
• Use of adequate contraception.
• Other inclusion criteria may apply.

Exclusion Criteria:

• Current diagnosis of either granulomatosis with polyangiitis or microscopic polyangiitis
• Imminently life-threatening EGPA at the time of screening.
• History or presence of any form of cancer within 5 years prior to screening.
• Serious liver, renal, blood, or psychiatric disease
• Severe or clinically significant cardiovascular disease uncontrolled with standard treatment
• Active systemic infections (including TB, pneumonia, Pneumocystis pneumonia, sepsis, and opportunistic infections)
• Parasitic infection: Subjects with a known parasitic infestation within 6 months prior to screening.
• HIV positive status
• Active hepatitis due to hepatitis B virus or hepatitis C virus
• Known history or presence of venous thromboembolism/venous thrombotic events (deep vein thrombosis and/or pulmonary embolus)
• laboratory parameter exclusions:

1. Estimated glomerular filtration rate of <30 mL/min/1.73 m2 by Chronic Kidney Disease Epidemiology Collaboration equations

2. WBC count <4 × 109/L

3. Absolute lymphocyte count <500 cells/mm3

4. Absolute neutrophil count <500 cells/mm3

5. Platelet count <120,000/mm3

6. Hemoglobin <8 g/dL (<80 g/L)

• Subjects who are pregnant, breastfeeding, or planning to become pregnant during the time of study participation
• History of clinically significant drug or alcohol abuse within the last 6 months
• Other exclusion criteria may apply.

Related Conditions & MeSH terms

• Churg-Strauss Syndrome
• Eosinophilic Granulomatosis With Polyangiitis
• Granulomatosis with Polyangiitis
• Systemic Vasculitis

Intervention

Drug:
• NS-229
Experimental
• Placebo
Placebo comparator

Locations

Country	Name	City	State
Japan	Juntendo University Hospital	Bunkyo-ku	Tokyo
Japan	Saitama Medical Center	Kawagoe	Saitama
Japan	Hospital of the University of Occupational and Environmental Health, Japan	Kitakyushu	Fukuoka
Japan	NHO Sagamihara National Hospital	Sagamihara	Kanagawa
Japan	Tohoku University Hospital	Sendai	Miyagi
United States	The Ohio State University Wexner Medical Center	Columbus	Ohio
United States	National Jewish Health	Denver	Colorado
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
NS Pharma, Inc.	Nippon Shinyaku Co., Ltd.

Countries where clinical trial is conducted

United States,  Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The proportion of subjects in remission [OGC 4.0]	The proportion of subjects in remission (oral glucocorticoid [OGC] 4.0) at Week 28 of the study treatment period.; Definition of remission (OGC 4.0): BVAS of 0 AND OGC dose of prednisolone/prednisone =4 mg/day	From Baseline to week 28
Secondary	The proportion of subjects in remission [OGC 7.5]	The proportion of subjects in remission (OGC 7.5) at Week 28 of the study treatment period Definition of remission (OGC 7.5): BVAS of 0 AND OGC dose of prednisolone/prednisone =7.5 mg/day	From Baseline to week 28
Secondary	Time to first relapse of EGPA	Relapse of EGPA will be defined as active disease since the last visit after remission (OGC 4.0) was achieved, characterized by: Active vasculitis (BVAS of >0); OR; Signs and/or symptoms of active asthma with a corresponding worsening in answers on the 6-item Asthma Control Questionnaire (compared with the most recent previous results); OR; Active nasal and/or sinus disease (attributable to EGPA) with a corresponding worsening in at least 1 of the answers on the sinonasal symptom questionnaire (compared with the most recent previous assessment).	Up to Week 28
Secondary	Time to first worsening of EGPA	Worsening of EGPA will be defined as worsening of active disease since the last visit, characterized by: Active vasculitis (BVAS >0) and the score greater than the previous visit; OR; Signs and/or symptoms of active asthma with a corresponding worsening in answers on the 6-item Asthma Control Questionnaire (compared to the most recent previous score); OR; Active nasal and/or sinus disease (attributable to EGPA) with a corresponding worsening in at least 1 of the answers on the sinonasal symptom questionnaire (compared to the most recent previous assessment).	Up to Week 28